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Hypersensitivity is an exaggerated response by the immune system to a drug or other substance.
Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Nektar Therapeutics reported today that partner Baxter International Inc. announced that the company has submitted a new drug application (NDA) to Japan's Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE [Antihemophilic Factor (Recombinant)] for patients over 12 years of age with hemophilia A. [More]
Nielsen BioSciences launches skin test that helps physicians manage Valley Fever infections

Nielsen BioSciences launches skin test that helps physicians manage Valley Fever infections

Nielsen BioSciences announced today the launch of SPHERUSOL (Coccidioides immitis Spherule-Derived Skin Test Antigen), a skin test that provides valuable data to physicians managing Valley Fever infections. SPHERUSOL has been approved by the U.S. Food and Drug Administration as the only skin test to detect an immune response to the fungus called Coccidioides, or "cocci," in patients with history of the disease. [More]
Combined therapy boosts growth in short children with low IGF-1

Combined therapy boosts growth in short children with low IGF-1

Children with short stature benefit from receiving combined treatment with growth hormone and insulin-like growth factor-1, if they have low endogenous levels of the latter, a study shows. [More]
Merck announces availability of GARDASIL 9 HPV vaccine in Canada

Merck announces availability of GARDASIL 9 HPV vaccine in Canada

Merck, known as MSD outside the United States and Canada, announced today that GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck's 9-valent human papillomavirus (HPV) vaccine, is now available in Canada. [More]
MOVANTIK (naloxegol) now available in U.S. for treatment of OIC in adult patients with non-cancer pain

MOVANTIK (naloxegol) now available in U.S. for treatment of OIC in adult patients with non-cancer pain

Nektar Therapeutics reported that partner AstraZeneca announced today that MOVANTIK (naloxegol) has launched in the United States. On September 16, 2014, the US Food and Drug Administration (FDA) approved MOVANTIK as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. [More]
Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira, Inc., a global leader in biosimilars and the world's leading provider of injectable drugs and infusion technologies, announces the availability of INFLECTRA (infliximab) in Canada, the country's first subsequent entry biologic (SEB) monoclonal antibody (mAb) therapy. [More]
Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced its plans for the commercialization of SPRIX (ketorolac tromethamine) Nasal Spray and OXAYDO (oxycodone HCI, USP) tablets for oral use only –CII. [More]
Glyxambi for Type 2 diabetes treatment now available by prescription across the U.S.

Glyxambi for Type 2 diabetes treatment now available by prescription across the U.S.

Glyxambi® (empagliflozin/linagliptin) tablets are now available by prescription in many leading chain and independent pharmacies across the U.S., including Walgreens and Rite Aid. [More]
Cosentyx (secukinumab) safe, effective for treating psoriasis patients

Cosentyx (secukinumab) safe, effective for treating psoriasis patients

Novartis today announced new two-year results demonstrating sustained efficacy with Cosentyx (secukinumab) with an acceptable safety profile for the treatment of psoriasis patients. The data comes from the extension study of the pivotal Phase III FIXTURE and ERASURE trials. [More]
Daiichi Sankyo signs co-commercialization agreement with AstraZeneca for MOVANTIK (naloxegol)

Daiichi Sankyo signs co-commercialization agreement with AstraZeneca for MOVANTIK (naloxegol)

Daiichi Sankyo, Inc. today announced a co-commercialization agreement with AstraZeneca for MOVANTIK (naloxegol) in the US, in line with the Daiichi Sankyo strategy to expand its US portfolio through strategic alliances, in addition to internal R&D and acquisitions. [More]
Egalet announces net revenues of $1.9 million for 2014

Egalet announces net revenues of $1.9 million for 2014

Egalet Corporation today reported financial results for the year ended December 31, 2014. [More]
United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. [More]
FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

Astellas today announced that the U.S. Food and Drug Administration has approved its New Drug Application (NDA) for the use of CRESEMBA (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). [More]
New article shows how marijuana can act as an allergen

New article shows how marijuana can act as an allergen

Growing up, you may have been given reasons for not smoking marijuana. What you may not have heard is that marijuana, like other pollen-bearing plants, is an allergen which can cause allergic responses. [More]
CEGIR launches patient contact registry for people with eosinophilic gastrointestinal diseases

CEGIR launches patient contact registry for people with eosinophilic gastrointestinal diseases

To coincide with Rare Disease Day 2015, the Consortium of Eosinophilic Gastrointestinal Disease Researchers today launched a patient contact registry for individuals with eosinophilic gastrointestinal diseases (EGID), a group of rare diseases. [More]
FDA approves LILETTA (levonorgestrel-releasing intrauterine system) to prevent pregnancy

FDA approves LILETTA (levonorgestrel-releasing intrauterine system) to prevent pregnancy

Actavis plc, a leading global specialty pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company, today announced the approval of LILETTA (levonorgestrel-releasing intrauterine system) by the U.S. Food and Drug Administration for use by women to prevent pregnancy for up to three years. [More]
Hospira announces launch of first biosimilar monoclonal antibody in Europe

Hospira announces launch of first biosimilar monoclonal antibody in Europe

Hospira, Inc., a world leader in the development of biosimilar therapies, today announced the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets. [More]
Jazz Pharmaceuticals to present defibrotide results for hepatic VOD at BMT Tandem meetings

Jazz Pharmaceuticals to present defibrotide results for hepatic VOD at BMT Tandem meetings

Jazz Pharmaceuticals plc announced today that researchers will present data on the use of defibrotide, an investigational medicine being studied in the United States (U.S.) for the treatment of hepatic veno-occlusive disease (VOD), a rare, potentially life-threatening, early complication in patients undergoing hematopoietic stem-cell transplantation (HSCT) therapy. [More]
Stomach ulcer bug H. pylori may reduce risk of developing multiple sclerosis

Stomach ulcer bug H. pylori may reduce risk of developing multiple sclerosis

A West Australian team has found evidence that the stomach ulcer bacterium, Helicobacter pylori, is associated with a lower risk of multiple sclerosis (MS), bolstering evidence for the role of the ‘hygiene hypothesis’ in autoimmune disorders. [More]
FDA approves Hospira's Dyloject (diclofenac sodium) Injection for pain management

FDA approves Hospira's Dyloject (diclofenac sodium) Injection for pain management

Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, has received approval from the U.S. Food and Drug Administration for Dyloject (diclofenac sodium) Injection, a proprietary nonsteroidal anti-inflammatory drug (NSAID) analgesic. [More]
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